Goruntla Narayana, Karisetty Basappa, Nandini Nandini, Bhupasamudram Bharadwaj, Gangireddy Himaja Reddy, Veerabhadrappa Kasturi Vishwanathasetty, Ezeonwumelu Joseph Obiezu Chukwujekwu, Bandaru Vishnuvandana
Department of Clinical Pharmacy and Pharmacy Practice, School of Pharmacy, Kampala International University, Western Campus, Uganda.
Department of Pharmacy Practice, Raghavendra Institute of Pharmaceutical Education and Research (RIPER) - Autonomous, Anantapur, Andhra Pradesh, India.
Vacunas. 2023 May 18. doi: 10.1016/j.vacun.2023.05.003.
Vaccine safety is a major barrier to the uptake of the COVID-19 vaccine by pregnant women. To bring confidence among pregnant women towards vaccine intake, there is a need to synthesize evidence on safety profile of vaccination.
To assess adverse events (AEs) following COVID-19 vaccination among pregnant women.
A vaccine safety surveillance was conducted at 2 rural primary health centers (PHC) located in Anantapur District, India. A total of 420 pregnant women were monitored for AEs following COVID-19 vaccination for a period of 30 min and followed for 1 month for late reactions through telephonic interviews. All AEs were subjected to causality and severity assessment. Descriptive statistics were used to represent adverse events.
The COVID-19 vaccine acceptance rate among pregnant women was 64.4%. A total of 420 pregnant women received 670 vaccine doses (Covishield = 372, Covaxin = 298) against COVID-19. Majority of vaccine intake was observed during the second trimester. The incidence rate of AEs following the COVID-19 vaccine among pregnant women was 93.8%, and the majority include injection site pain (28.4%, 29.6%), fever (25.5%, 19.0%), myalgia (8.21%, 12.3%), and malaise (13.6%, 8.4%). Most AEs notified are probable and mild in nature.
The COVID-19 vaccine acceptance rate among pregnant women was 64.4%. A 30 days incidence rate of AEs following COVID-19 vaccination among pregnant women was 93.8%, with the most common mild events like injection site pain, and fever. A further follow-up cohort study by taking an adequate sample size was recommended to capture fetal-maternal outcomes.
疫苗安全性是孕妇接种新冠疫苗的一个主要障碍。为了让孕妇对接种疫苗产生信心，有必要综合关于疫苗安全性的证据。
评估孕妇接种新冠疫苗后的不良事件（AE）。
在印度阿南塔布尔区的2个农村初级卫生中心（PHC）开展了疫苗安全性监测。对420名孕妇接种新冠疫苗后的不良事件进行了30分钟的监测，并通过电话访谈对迟发反应进行了1个月的随访。所有不良事件均进行了因果关系和严重程度评估。采用描述性统计来呈现不良事件。
孕妇对新冠疫苗的接受率为64.4%。共有420名孕妇接种了670剂新冠疫苗（科维希德疫苗=372剂，科瓦克辛疫苗=298剂）。大部分疫苗接种发生在孕中期。孕妇接种新冠疫苗后不良事件的发生率为93.8%，其中大多数包括注射部位疼痛（28.4%，29.6%）、发热（25.5%，19.0%）、肌痛（8.21%，12.3%）和不适（13.6%，8.4%）。报告的大多数不良事件可能发生且性质轻微。
孕妇对新冠疫苗的接受率为64.4%。孕妇接种新冠疫苗后30天内不良事件的发生率为93.8%，最常见的是注射部位疼痛和发热等轻微事件。建议进行进一步的队列研究，采用足够的样本量以获取胎儿-母体结局。
